Back to resultsCONtrolled Focal Fibrous Band Release Method Study (CONFFIRM)
Primary Purpose
Cellulite
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Avéli device
Sponsored by
About this trial
This is an interventional treatment trial for Cellulite
Eligibility Criteria
Inclusion Criteria:
- Moderate to severe cellulite
Exclusion Criteria:
- Body Mass Index ≥30.0
Sites / Locations
- Clinical Site #3
- Clinical Site #5
- Clinical Site #4
- Clinical Site #2
- Clinical Site #6
- Clinical Site #8
- Clinical Site #1
- Clinical Site #7
- Clinical Site #9
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Targeted Verifiable Subcision (TVS) with the Avéli device, mITT
Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in
Arm Description
Modified intent to treat population (n=68). The modified intent to treat population was used to evaluate effectiveness. The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks
The roll-in population (n=6) was excluded from the effectiveness analyses. For Investigators that have not previously performed an Avéli procedure, two (2) participants were classified as roll-in participants. The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks
Outcomes
Primary Outcome Measures
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants
The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment.
CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1
PART A- Number of evident depressions 0 None
Mild (≤4 depressions)
Moderate (5 to 9 depressions)
Severe (≥ 10 depressions) PART B - Average depth of depressions
0 None
Mild (1-2 mm)
Moderate (3-4 mm)
Severe (≥5 mm)
Secondary Outcome Measures
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months
The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6.
Scale: -3:very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months
The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3).
Scale: -3: very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.
The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants
The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment.
CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1
PART A- Number of evident depressions 0 None
Mild (≤4 depressions)
Moderate (5 to 9 depressions)
Severe (≥ 10 depressions) PART B - Average depth of depressions
0 None
Mild (1-2 mm)
Moderate (3-4 mm)
Severe (≥5 mm)
The Percentage of Patients Satisfied With Their Results at 3 Months
Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 3 months. The outcome measure reports the percentage of participants satisfied with their results at 3 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses.
The lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.
The Number of Patients Satisfied With Their Results at 12 Months
Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 12 months. The outcome measure reports the number of participants satisfied with their results at 12 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04743635
Brief Title
CONtrolled Focal Fibrous Band Release Method Study
Acronym
CONFFIRM
Official Title
CONtrolled Focal Fibrous Band Release Method Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
June 14, 2021 (Actual)
Study Completion Date
March 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revelle Aesthetics, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.
Detailed Description
Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants were treated with the Avéli device.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted Verifiable Subcision (TVS) with the Avéli device, mITT
Arm Type
Experimental
Arm Description
Modified intent to treat population (n=68). The modified intent to treat population was used to evaluate effectiveness.
The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks
Arm Title
Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in
Arm Type
Experimental
Arm Description
The roll-in population (n=6) was excluded from the effectiveness analyses. For Investigators that have not previously performed an Avéli procedure, two (2) participants were classified as roll-in participants. The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks
Intervention Type
Device
Intervention Name(s)
Avéli device
Intervention Description
Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
Primary Outcome Measure Information:
Title
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants
Description
The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment.
CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1
PART A- Number of evident depressions 0 None
Mild (≤4 depressions)
Moderate (5 to 9 depressions)
Severe (≥ 10 depressions) PART B - Average depth of depressions
0 None
Mild (1-2 mm)
Moderate (3-4 mm)
Severe (≥5 mm)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months
Description
The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6.
Scale: -3:very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.
Time Frame
3 months
Title
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months
Description
The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3).
Scale: -3: very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.
Time Frame
12 Months
Title
The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants
Description
The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment.
CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1
PART A- Number of evident depressions 0 None
Mild (≤4 depressions)
Moderate (5 to 9 depressions)
Severe (≥ 10 depressions) PART B - Average depth of depressions
0 None
Mild (1-2 mm)
Moderate (3-4 mm)
Severe (≥5 mm)
Time Frame
12 months
Title
The Percentage of Patients Satisfied With Their Results at 3 Months
Description
Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 3 months. The outcome measure reports the percentage of participants satisfied with their results at 3 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses.
The lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.
Time Frame
3 month
Title
The Number of Patients Satisfied With Their Results at 12 Months
Description
Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 12 months. The outcome measure reports the number of participants satisfied with their results at 12 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses.
Time Frame
12 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Moderate to severe cellulite
Exclusion Criteria:
Body Mass Index ≥30.0
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. G. William Stevens, MD
Organizational Affiliation
Marina Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Site #3
City
Los Angeles
State/Province
California
ZIP/Postal Code
90292
Country
United States
Facility Name
Clinical Site #5
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Clinical Site #4
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Clinical Site #2
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Clinical Site #6
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Clinical Site #8
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
Clinical Site #1
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Clinical Site #7
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Clinical Site #9
City
Toowoomba
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to share Executive Summary of Protocol. No formal, separate SAP for this study.
IPD Sharing Time Frame
Will post Protocol Executive Summary on June 14, 2022. It will be available indefinitely.
Learn more about this trial
CONtrolled Focal Fibrous Band Release Method Study
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